- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00330005
A Pilot Study of Psychodynamic Psychotherapy for Bipolar Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The psychotherapy literature suggests that psychological treatments can have a significant impact on the clinical course and outcome for bipolar disorder (Swartz & Frank, 2001). Very few outcome studies have been conducted in group psychotherapy for bipolar disorder, and there are no preliminary studies conducted using the Integrative Outpatient Model, developed specifically for bipolar disorder. Given the lack of preliminary data, a pilot study with a matched-control design is indicated to obtain preliminary data regarding this treatment modality and approach. The IOM is a weekly, long term psychotherapy.
Comparison: Individuals who participate in group psychotherapy will be compared to a control group on mood and symptom ratings, up to 1 year post intervention.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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San Antonio, Texas, United States, 78212
- University of Texas Health Science Center - Department of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:bipolar disorder; functioning level appropriate for outpatient group psychotherapy; willingness to engage in a psychotherapeutic intervention -
Exclusion Criteria: cognitive impairment; prominent psychosis; under 18 years old
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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depression symptoms
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manic symptoms
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number of days without a bipolar mood episode
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global assessment of functioning
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clinical global impression for bipolar disorder
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Collaborators and Investigators
Investigators
- Principal Investigator: Jodi M Gonzalez, PhD, The University of Texas Health Science Center at San Antonio
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FFPR-001
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